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首页> 外文期刊>Journal of Diabetes Science and Technology >A Hazard Analysis for a Generic Insulin Infusion Pump
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A Hazard Analysis for a Generic Insulin Infusion Pump

机译：普通胰岛素输液泵的危害分析

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Background: Researchers at the Food and Drug Administration (FDA)/Center for Device and Radiological Health/Office of Science and Engineering Laboratories have been exploring the concept of model-based engineering as a means for improving the quality of medical device software. Insulin pumps were chosen as a research subject because their design provides the desired degree of research complexity and these types of devices present an ongoing regulatory challenge. Methods: Insulin pump hazards and their contributing factors are considered in the context of a highly abstract generic insulin infusion pump (GIIP) model. Hazards were identified by consulting with manufacturers, pump users, and clinicians; by reviewing national and international standards and adverse event reports collected by the FDA; and from workshops sponsored by Diabetes Technology Society. This information has been consolidated in tabular form to facilitate further community analysis and discussion. Results: A generic insulin infusion pump model architecture has been established. A fairly comprehensive hazard analysis document, corresponding to the GIIP model, is presented in this article. Conclusions: We believe that this work represents the genesis of an insulin pump safety reference standard upon which future insulin pump designs can be based to help ensure a basic level of safety. More interaction with the diabetes community is needed to assure the quality of this safety modeling process.
机译：背景：美国食品药品管理局（FDA）/设备与放射健康中心/科学与工程实验室办公室的研究人员一直在探索基于模型的工程概念，以提高医疗器械软件的质量。选择胰岛素泵作为研究对象是因为它们的设计提供了所需程度的研究复杂性，并且这些类型的设备提出了持续的监管挑战。方法：在高度抽象的通用胰岛素输注泵（GIIP）模型的背景下，考虑了胰岛素泵的危害及其影响因素。通过与制造商，泵用户和临床医生进行协商来确定危害。通过审查FDA收集的国家和国际标准以及不良事件报告;以及由糖尿病技术协会主办的研讨会。此信息已以表格形式合并，以方便进一步的社区分析和讨论。结果：建立了通用的胰岛素输液泵模型架构。本文提供了与GIIP模型相对应的相当全面的危害分析文档。结论：我们认为这项工作代表了胰岛素泵安全性参考标准的起源，未来的胰岛素泵设计可以以此为基础来帮助确保基本的安全性。需要与糖尿病社区进行更多互动，以确保此安全建模过程的质量。

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